Real-World Evidence of NEPA, Netupitant-Palonosetron, in Chemotherapy-Induced Nausea and Vomiting Prevention: Effects on Quality of Life

Karthaus, Meinolf; Oskay-Özcelik, G.; Wülfing, P.; Hielscher, Carsten; Guth, Dagmar; Zahn, Mark‐Oliver; Flahaut, Elisa; Schilling, Jörg

doi:10.2217/fon-2020-0187

Cited by 24 publications

(51 citation statements)

References 45 publications

(77 reference statements)

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“…Simple administration schedules not only could facilitate adherence by physicians but also could prevent patients from making medication mistakes, a recurring problem during home administration in the delayed phase [32]. In line with this, a recent noninterventional study evaluating patient‐reported outcomes during the use of NEPA in routine clinical practice showed similar antiemetic efficacy as in the controlled pivotal trials, suggesting high treatment compliance by patients under real‐world conditions [46]. On the other hand, a recent phase IV study demonstrated lower antiemetic effectiveness of the aprepitant/fosaprepitant‐palonosetron‐dexamethasone regimen in the real world as compared with the reported efficacy in randomized controlled trials [47, 48].…”

Section: Discussionmentioning

confidence: 93%

Practice Patterns for Prevention of Chemotherapy-Induced Nausea and Vomiting and Antiemetic Guideline Adherence Based on Real-World Prescribing Data

et al. 2021

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Background. Guideline-recommended antiemetic prophylaxis improves nausea and vomiting control in most patients undergoing chemotherapy. Multinational Association of Supportive Care in Cancer/European Society for Medical Oncology (MASCC/ESMO) antiemetic guidelines recommend prophylaxis with a neurokinin-1 receptor antagonist (NK 1 RA), a 5-hydroxytryptamine-3 (5-HT 3)RA, and dexamethasone for patients receiving highly emetogenic chemotherapy (HEC), including anthracycline-cyclophosphamide (AC)-and carboplatin (considered moderately emetogenic chemotherapy)-based chemotherapy. Here, we analyze the use of NK 1 RA-5-HT 3 RA-dexamethasone for antiemetic prophylaxis associated with HEC and carboplatin. Methods. The data source was the Global Oncology Monitor (Ipsos Healthcare). Geographically representative physicians from France, Germany, Italy, Spain, and UK were screened for treatment involvement and number of patients treated/month. Patients' data from Jan-Dec 2018 were collected from medical charts and extrapolated on the basis of the total number of physicians who prescribe chemotherapy. The emetic risk of chemotherapy was classified per MASCC/ESMO guidelines. Results. Data from 45,324 chemotherapy-treated patients were collected, representing a total extrapolated prevalence of 1,394,848 chemotherapy treatments included in the analysis. NK 1 RAs were used in 45%/42%/19% of patients receiving cisplatin-/AC-/carboplatin-based chemotherapy, respectively; 18%/24%/7% received the guidelinerecommended NK 1 RA-5-HT 3 RA-dexamethasone combination; no antiemetics were prescribed for 12% of the treatments. Often, physicians' perception of the emetic risk of chemotherapy did not follow MASCC/ESMO guideline classification. Conclusion. Low adherence to antiemetic guidelines was revealed in clinical practice in five European countries, with 15% of all HEC-/carboplatin-based treatments receiving guideline-recommended NK 1 RA-5-HT 3 RA-dexamethasone prophylaxis, and 12% of them receiving no antiemetics. New strategies for improving guideline adherence are urgently needed. The Oncologist 2021;9999:• • Implications for Practice: Despite recent advances in antiemetic therapy, a substantial proportion of patients experience nausea and vomiting associated with chemotherapy in daily clinical practice. Antiemetic guidelines aim at prevention of chemotherapy-induced nausea and vomiting (CINV) and guideline-consistent antiemetic therapy can effectively prevent vomiting and, to a lesser extent, nausea in most patients with cancer. This study reports low adherence to antiemetic guidelines in the highly emetogenic chemotherapy setting in daily clinical practice across five European countries. Opportunity

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Section: Discussionmentioning

confidence: 93%

Practice Patterns for Prevention of Chemotherapy-Induced Nausea and Vomiting and Antiemetic Guideline Adherence Based on Real-World Prescribing Data

et al. 2021

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“…Another example of reduced effectiveness in a real‐world setting was shown in a recent prospective, observational trial exploring the effectiveness of aprepitant/fosaprepitant in a heterogenous population receiving predominantly cisplatin‐based HEC or AC; an overall complete response rate of just 34% was seen in the AC subset [33]. A prior NEPA real‐life noninterventional study was conducted in a large heterogenous population of 2,173 patients with various tumor types receiving a variety of HEC and MEC [34]. Reassuringly, the response rates seen in that study were consistent with those shown in the pivotal NEPA studies.…”

Section: Discussionmentioning

confidence: 99%

A Pragmatic Study Evaluating NEPA Versus Aprepitant for Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy

et al. 2021

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Background. Neurokinin (NK) 1 receptor antagonists (RA), administered in combination with a 5-HT 3 RA and dexamethasone (DEX), have demonstrated clear improvements in CINV prevention over a 5-HT 3 RA plus DEX. However, studies comparing the NK 1 RAs in the class are lacking. NEPA, a fixed combination of a highly selective NK 1 RA, netupitant, and the 5-HT 3 RA, palonosetron, simultaneously targets two critical antiemetic pathways, thereby offering a simple convenient antiemetic with long-lasting protection from CINV. This study is the first head-to-head NK 1 RA comparative study in patients receiving anthracycline cyclophosphamide (AC) and non-AC moderately emetogenic chemotherapy (MEC). Patients and Methods. This was a pragmatic, multicenter, randomized, single-cycle, open-label, prospective study designed to demonstrate non-inferiority of single-dose NEPA to a 3-day aprepitant regimen in preventing CINV in chemotherapy-naïve patients receiving AC/non-AC MEC in a real-life setting. The primary efficacy endpoint was complete response (no emesis/no rescue) during the overall (0-120h) phase. Non-inferiority was achieved if the lower limit of the 95% CI of the difference between NEPA and the aprepitant group was greater than the non-inferiority margin set at -10%. Results. Non-inferiority of NEPA versus aprepitant was demonstrated (risk difference 9.2%; 95% CI -2.3%, 20.7%); the overall complete response rate was numerically higher for NEPA (64.9%) than aprepitant (54.1%). Secondary endpoints also revealed numerically higher rates for NEPA than aprepitant. Conclusion. This pragmatic study in cancer patients receiving AC and non-AC MEC revealed that a single dose of oral NEPA plus DEX was at least as effective as a 3-day aprepitant regimen, with indication of a potential efficacy benefit for NEPA. The Oncologist ;9999:• • Implications for Practice: In the absence of comparative NK 1 receptor antagonist (RA) studies, guideline committees and clinicians consider NK 1 RA agents to be interchangeable and equivalent. This is the first head-to-head study comparing one NK 1 RA (oral NEPA [netupitant/palonosetron]) versus another (aprepitant) in patients receiving anthracycline cyclophosphamide (AC) and non-AC moderately emetogenic chemotherapy. Non-inferiority of NEPA versus the aprepitant regimen was demonstrated; the overall complete response (no emesis and no rescue use) rate was numerically higher for NEPA (65%)

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“…Evidence for the effectiveness of oral netupitant/palonosetron in preventing CINV in the real-world setting is available from a prospective, non-interventional study conducted in Germany in 2429 adults receiving HEC or MEC for three cycles [ 27 ]. Netupitant/palonosetron was administered according to the EU label (Sect.…”

Section: Therapeutic Efficacy Of Nepamentioning

confidence: 99%

“…In the HEC and MEC groups, respectively, 84–88% and 82–87% of patients reported no impact on daily life (NIDL) due to vomiting across cycles 1–3, 54–58% and 59–66% reported NIDL due to nausea, and 64–66% and 67–74% reported NIDL for the combined domain of nausea and vomiting [ 27 ]. Overall, high CR rates were also observed across cycles 1–3 (89.2–90.9%, 86.9–87.1% and 82.5–83.6% in the acute, delayed and overall phases, respectively).…”

Section: Therapeutic Efficacy Of Nepamentioning

confidence: 99%

Netupitant/Palonosetron: A Review in Chemotherapy-Induced Nausea and Vomiting

Shirley

2021

Drugs

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Netupitant/palonosetron (NEPA; Akynzeo ® ), available in oral and intravenous (IV) formulations, is a fixed-dose combination of the neurokinin 1 (NK1) receptor antagonist netupitant (or the prodrug, fosnetupitant, in the IV formulation) and the second-generation serotonin 3 (5-HT 3 ) receptor antagonist palonosetron. Administered as a single dose, (fos)netupitant/palonosetron (in combination with dexamethasone) is indicated for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in adults. In clinical trials, (fos)netupitant/palonosetron plus dexamethasone was associated with high complete response rates (no emesis and no rescue medication) in the acute, delayed and overall phases in patients receiving highly or moderately emetogenic chemotherapy, with efficacy maintained over multiple cycles. Further, oral netupitant/palonosetron was found to be superior to palonosetron and non-inferior to aprepitant plus granisetron in preventing CINV in individual trials. Both the oral and IV formulations of the drug combination are well tolerated. The fixed-dose combination is concordant with guideline recommendations and provides a simple and convenient option for prophylaxis against acute and delayed CINV in patients receiving highly or moderately emetogenic chemotherapy. Supplementary Information The online version contains supplementary material available at 10.1007/s40265-021-01558-2.

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Real-World Evidence of NEPA, Netupitant-Palonosetron, in Chemotherapy-Induced Nausea and Vomiting Prevention: Effects on Quality of Life

Cited by 24 publications

References 45 publications

Practice Patterns for Prevention of Chemotherapy-Induced Nausea and Vomiting and Antiemetic Guideline Adherence Based on Real-World Prescribing Data

Practice Patterns for Prevention of Chemotherapy-Induced Nausea and Vomiting and Antiemetic Guideline Adherence Based on Real-World Prescribing Data

A Pragmatic Study Evaluating NEPA Versus Aprepitant for Prevention of Chemotherapy-Induced Nausea and Vomiting in Patients Receiving Moderately Emetogenic Chemotherapy

Netupitant/Palonosetron: A Review in Chemotherapy-Induced Nausea and Vomiting

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